Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "bundle-drug-product-excipients-pq-ex1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-excipients-pq"
]
},
"type" : "collection",
"entry" : [
// MedicinalProductDefinition - the main resource in any product scenario
{
"fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"resource" : // Section 1.1 - DP Identification
{
"resourceType" : "MedicinalProductDefinition",
"id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"text" : // medicinalproductdefinition-drug-product-dxpq-ex1
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" </p></div><p><b>description</b>: Stelbatalol is formulated as an immediate-release, oral, solid dosage form in strengths of 20 mg of the free base equivalent. The 20 mg strength is presented as an orange, round, film coated tablet, debossed with '175' on one side.</p><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#20053000)</span></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ProductName</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Stalbatolol</td><td>Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-productNameType-local-pq.html\">CodeSystem - Product Name Type</a>#Proprietary)</span></td></tr></table><blockquote><p><b>characteristic</b></p><p><b>Extension - Substance Property Range PQ</b>: 23-27 mg/mL</p><p><b>type</b>: Solubility purified water <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-local-pq.html\">CodeSystem - Substance Property</a>#solubility-water)</span></p></blockquote><blockquote><p><b>characteristic</b></p><p><b>type</b>: Water content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-local-pq.html\">CodeSystem - Substance Property</a>#water-content)</span></p><p><b>value</b>: 23 mg/mL</p></blockquote></div>"
},
"description" : "Stelbatalol is formulated as an immediate-release, oral, solid dosage form in strengths of 20 mg of the free base equivalent. The 20 mg strength is presented as an orange, round, film coated tablet, debossed with '175' on one side.",
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "10225000",
"display" : "Gastro-resistant tablet"
}
]
},
"route" : [
{
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "20053000",
"display" : "Oral use"
}
]
}
],
"name" : [
{
"productName" : "Stalbatolol",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-local-pq",
"code" : "Proprietary",
"display" : "Proprietary"
}
]
}
}
],
"characteristic" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq",
"valueRange" : {
"low" : {
"value" : 23,
"unit" : "mg/mL"
},
"high" : {
"value" : 27,
"unit" : "mg/mL"
}
}
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq",
"code" : "solubility-water",
"display" : "Solubility purified water"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq",
"code" : "water-content",
"display" : "Water content"
}
]
},
"valueQuantity" : {
"value" : 23,
"unit" : "mg/mL"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:1e82ce23-7c09-2248-7a29-d7c65a06616b",
"resource" : {
"resourceType" : "Organization",
"id" : "1e82ce23-7c09-2248-7a29-d7c65a06616b",
"text" : // manufacturerPG
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"1e82ce23-7c09-2248-7a29-d7c65a06616b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "1e82ce23-7c09-2248-7a29-d7c65a06616b" </p></div><p><b>identifier</b>: id:\u00a03010027651</p><p><b>name</b>: Modified Sugar, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>381 Main Street Lumberton New Jersey 08048 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3010027651"
}
],
"name" : "Modified Sugar, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"381 Main Street"
],
"city" : "Lumberton",
"state" : "New Jersey",
"postalCode" : "08048",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:1e82ce23-7c09-2248-7a29-d7c65a06616c",
"resource" : {
"resourceType" : "Organization",
"id" : "1e82ce23-7c09-2248-7a29-d7c65a06616c",
"text" : // manufacturerDGA
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"1e82ce23-7c09-2248-7a29-d7c65a06616c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "1e82ce23-7c09-2248-7a29-d7c65a06616c" </p></div><p><b>identifier</b>: id:\u00a03012027651</p><p><b>name</b>: Plasma Source, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>351 Main Street Lumberton New Jersey 08048 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3012027651"
}
],
"name" : "Plasma Source, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"351 Main Street"
],
"city" : "Lumberton",
"state" : "New Jersey",
"postalCode" : "08048",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a6b",
"resource" : {
"resourceType" : "Ingredient",
"id" : "b89ed9d2-80f9-0cfb-70a1-5a6572e73a6b",
"text" : // ingredient1
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"b89ed9d2-80f9-0cfb-70a1-5a6572e73a6b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Ingredient "b89ed9d2-80f9-0cfb-70a1-5a6572e73a6b" </p></div><p><b>Extension - Novel Excipient PQ</b>: true</p><p><b>Extension - Suitability for Use PQ</b>: Excipient has been certified for use in human medicinal products</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_1e82ce23-7c09-2248-7a29-d7c65a06616b\">See above (Organization/1e82ce23-7c09-2248-7a29-d7c65a06616b)</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_4cf2cbba-33e6-1124-9bf2-1c6756380474\">See above (SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380474)</a></td></tr></table></blockquote></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq",
"valueString" : "Excipient has been certified for use in human medicinal products"
}
],
"status" : "active",
"for" : [
{
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
],
"role" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
{
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/1e82ce23-7c09-2248-7a29-d7c65a06616b"
}
}
],
"substance" : // Organization/manufacturerPG
{
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380474"
}
}
}
}
},
// SubstanceDefinition/pg
{
"fullUrl" : "urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380474",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "4cf2cbba-33e6-1124-9bf2-1c6756380474",
"text" : // pg
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"4cf2cbba-33e6-1124-9bf2-1c6756380474\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380474" </p></div><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Pegylated glucose</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td>mineral <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-substance-source-material-type.html\">Substance Source Material Type</a>#Mineral)</span></td><td>United Kingdom <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#GBR)</span></td></tr></table></div>"
},
"name" : [
{
"name" : "Pegylated glucose"
}
],
"sourceMaterial" : {
"type" : {
"coding" : [
// to mean "non-biological"
{
"system" : "http://hl7.org/fhir/substance-source-material-type",
"code" : "Mineral",
"display" : "mineral"
}
]
},
"countryOfOrigin" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "GBR",
"display" : "United Kingdom"
}
]
}
]
}
}
},
{
"fullUrl" : "urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a7b",
"resource" : {
"resourceType" : "Ingredient",
"id" : "b89ed9d2-80f9-0cfb-70a1-5a6572e73a7b",
"text" : // ingredient2
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"b89ed9d2-80f9-0cfb-70a1-5a6572e73a7b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Ingredient "b89ed9d2-80f9-0cfb-70a1-5a6572e73a7b" </p></div><p><b>Extension - Suitability for Use PQ</b>: Excipient is derived from plasma certified to originate from healthy animals and is irradiated prior to distribution. In addition, albumin is not prepared with the use of other ruminant materials.</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#Organization_1e82ce23-7c09-2248-7a29-d7c65a06616c\">See above (Organization/1e82ce23-7c09-2248-7a29-d7c65a06616c)</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_4cf2cbba-33e6-1124-9bf2-1c6756380475\">See above (SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380475)</a></td></tr></table></blockquote></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq",
"valueString" : "Excipient is derived from plasma certified to originate from healthy animals and is irradiated prior to distribution. In addition, albumin is not prepared with the use of other ruminant materials."
}
],
"status" : "active",
"for" : [
{
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
],
"role" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
{
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072082",
"display" : "Excipient"
}
]
},
"manufacturer" : [
{
"manufacturer" : {
"reference" : "Organization/1e82ce23-7c09-2248-7a29-d7c65a06616c"
}
}
],
"substance" : // Organization/manufacturerDGA
{
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380475"
}
}
}
}
},
// SubstanceDefinition/dga
{
"fullUrl" : "urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380475",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "4cf2cbba-33e6-1124-9bf2-1c6756380475",
"text" : // dga
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"4cf2cbba-33e6-1124-9bf2-1c6756380475\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380475" </p></div><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Deactivated goat albumin</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Species</b></td><td><b>Part</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td>animal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-substance-source-material-type.html\">Substance Source Material Type</a>#Animal)</span></td><td>animal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-substance-source-material-part.html\">Substance Source Material Part</a>#Animal)</span></td><td>animal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-substance-source-material-type.html\">Substance Source Material Type</a>#Animal)</span></td><td>United States of America <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#USA)</span></td></tr></table></div>"
},
"name" : [
{
"name" : "Deactivated goat albumin"
}
],
"sourceMaterial" : {
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/substance-source-material-type",
"code" : "Animal",
"display" : "animal"
}
]
},
"species" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/substance-source-material-part",
"code" : "Animal",
"display" : "animal"
}
]
},
"part" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/substance-source-material-type",
"code" : "Animal",
"display" : "animal"
}
]
},
"countryOfOrigin" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "USA",
"display" : "United States of America"
}
]
}
]
}
}
}
]
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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